Abortion in Second Trimester
Conditions
Brief summary
The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.
Interventions
None listed
Sponsors
Gynuity Health Projects
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Meet legal criteria to obtain abortion * Have an ongoing pregnancy of 13-22 weeks gestation * Be willing to undergo a surgical completion if necessary * Have no contraindications to study procedures, according to provider * Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her * Be willing to follow study procedures
Exclusion criteria
* Known previous transmural uterine incision * Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol * Any contraindications to vaginal delivery, including placenta previa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of abortions that are complete as a measure of efficacy | At 15 hours after the start of misoprostol administration | It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Women's satisfaction with the method | At discharge, up to 5 days after enrollment | It is a scale that assesses the level of a woman's satisfaction with the procedure. |
| Side effects experienced by women | Every 3 hours from the start of misoprostol administration until complete abortion | It is a brief questionnaire that records all side effects experienced by women. |
| Pain experienced by women | At the time of discharge, up to 5 days after enrollment | It is a scale that assesses the acceptability of pain experienced by the woman. |
| Interval of time between induction with misoprostol to complete abortion | Every 3 hours from the start of misoprostol administration until complete abortion | It is the length of time between the administration of the first dose of misoprostol and complete abortion. |
| Women's perception of acceptability of the procedure | At discharge, up to 5 days after enrollment | It is a scale that assesses the acceptability of the procedure for the woman. |
| Provider's perception of acceptability of the method | At study completion, up to 2 years after study enrollment commences | It is a questionnaire that assesses the acceptability of the method for the provider. |
| Total dose of misoprostol administered | Every 3 hours from start of misoprostol administration to complete abortion | Count of the total dose of misoprostol administered from the first dose to complete abortion. |
| Complications during induction and after discharge | Every 3 hours from the start of misoprostol administration, up to 1 month after discharge | It is a record of complications and their treatment during induction and up to 1 month after discharge. |
Countries
Uzbekistan
Outcome results
None listed